Program Director/Principal Investigator (Last, First, Middle): Kisler, Bron Witt Development of CDISC Therapeutic Area Standard for Colorectal Cancer Project Summary The objective of this project is to develop a global, non-proprietary CDISC data standard for Colorectal Cancer, utilizing the CDISC standards development process. Colorectal Cancer is the 2nd leading cause of cancer related deaths in the United States, which carries significant costs for research and treatment. The CDISC Therapeutic Area Standard for Colorectal Cancer will be used in regulatory submissions as well as data collection for new clinical trials. The Specific Aims of this project include: ? Work through existing partnerships with FDA and NCI as well as the broader cancer research community to develop a CDISC Therapeutic Area Standard for Colorectal Cancer using the CDISC standards development process. ? Ensure alignment with the CDISC SDTM standard for electronic regulatory submissions to the FDA. ? Through our long-standing partnership with National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS), provide applicable oncology research concepts and controlled terminology coded in the NCI EVS terminology system. ? Use the CDISC SHARE Metadata Repository and other tools to support development of the Colorectal Cancer data standard. ? Publish a CDISC Therapeutic Area Standard for Colorectal Cancer, making it publicly available through the CDISC website. This project will be accomplished through several distinct stages as part of the CDISC therapeutic area standards development process: ? Stage 0 ? Initiation and Scoping: Review and approval of project proposal and define scope. ? Stage 1 ? Identification of Research Concepts: Create multi-disciplinary core team (including FDA contact), review available prior work, design concept maps, create new concept map templates, and perform gap analysis with existing CDISC constructs. ? Stage 2 ? Development of Draft Standards: Core team develops detailed metadata for SHARE in SDTM format, draft user guide. ? Stage 3.1 ? Internal Review: Review of draft standards by relevant CDISC teams and experts in Colorectal Cancer. ? Stage 3.2 ? Public Review: Review of draft standards by general public for a minimum of 30 days, approve as a final production standard. ? Stage 3.3 ? Public Release: Data standard posted to CDISC website. ? Use CDISC SHARE Metadata Repository and other electronic tools to maximize the reuse of existing metadata and controlled terminology.